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OpenTrials
Completed

NCT Number: NCT00600392

DNA/RNA Analysis of Blood and Skeletal Muscle in Patients Undergoing Cardiac Resynchronization Therapy (CRT)

Genes expressing inflammatory cytokines (TNF- alpha, IL1 etc) and genes involved in apoptosis (Caspase 3, Bax, Bcl-2, Fas) are dysregulated in the skeletal muscles of the patients who have muscle wasting and decreased exercise capacity with CHF.

Patients who show benefit from CRT may also show reversal of the inflammatory/apoptotic cascade that accompanies CHF and these patients may be the ones who benefit the most from CRT

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

  • The general objective of this study is to:
  • To identify the molecular pathways that may be altered in the blood and skeletal muscles of the patients undergoing CRT by using transcriptional analysis of the blood and skeletal muscle in these patients
  • To identify objective measurable molecular signals, using gene expression profiling, that correlate with clinical improvement in patients undergoing CRT.
  • To identify the molecular profile of patients who are most likely to benefit from CRT with improvement of exercise capacity and reversal of cardiac cachexia.
  • To identify biochemical pathways involved in cardiac cachexia.
  • To identify genes involved in positive remodeling and reversal of apoptotic cascade in the skeletal muscle.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with poor LV function and an EF of ≤35%
  • Patients who are symptomatic with Class II or Class III heart failure on optimal medical therapy.
  • Patients with EKG showing QRS duration of greater than 120 ms and meet criteria for Bi-ventricular ICD implantation.

Exclusion criteria

  • Patients with other co-morbid conditions which could contribute to cachexia, such as end stage renal disease, ongoing malignancy, chronic or acute liver failure, age greater than 80yrs.
  • Patients who are unable to walk and are wheelchair bound or need assistance to walk for reasons other than CHF.
  • Patients with muscular dystrophies and myopathies.
  • Patients with untreated hyper or hypothyroidism.
  • Patients on Dialysis.
  • Patients with recent (<12 weeks) revascularization.
  • Patients with recent (<12 weeks) myocardial infarction.

Treatment and study plan

Primary outcomes

  1. Shift of the muscle transcriptome away from Apoptosis/Inflammation. Reversal of active apoptosis in skeletal muscle.Quality of life assessment(Minn.HF Ques) Exercise capacity (6 min walk).

    Time frame: 6 months

Secondary outcomes

  1. Improved LV synchrony as determined by TDI, Decrease in blood markers of inflammation and Oxidative stress and catabolism.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Transcriptomal Analysis of Peripheral Blood and Skeletal Muscle in Patients Undergoing CRT Using Oligonucleotide Arrays

Acronym: Medusa PH

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Jan 25, 2008
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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